BETACIN EYEEAR DROPS

Pays: Malaisie

Langue: anglais

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingrédients actifs:

BETAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULPHATE

Disponible depuis:

DUOPHARMA (M) SDN. BHD.

DCI (Dénomination commune internationale):

BETAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULPHATE

Unités en paquet:

5ml mL

Fabriqué par:

DUOPHARMA (M) SDN. BHD.

Notice patient

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
BETACIN EYE/EAR DROPS
®
Neomycin sulphate / Betamethasone Phosphate (0.5% w/v / 0.1% w/v)
WHAT IS IN THE LEAFLET
1.
What Betacin is used for
2.
How Betacin works
3.
Before you use Betacin
4.
How to use Betacin
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Betacin
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT BETACIN IS USED FOR
Betacin is a medicine which is
used
in
inflammatory
conditions
of
the
eye
or
ear
where
there
is
bacterial
infection.
HOW BETACIN WORKS
Neomycin
sulphate
is
an
antibiotic
which
can
help
to
treat certain types of infections.
Betamethasone
phosphate
reduces inflammation and can
help to relieve the symptoms of
inflammatory
eye
or
ear
problems.
BEFORE YOU USE BETACIN
-
_When you must not use it _
_Pregnancy and lactation _
_ _
No
problems
have
been
documented for Betacin use in
breast-feeding.
Infants
born
to
mothers
who
have received substantial doses
of
corticosteroids
should
be
observed
for
signs
of
under
activity of the adrenal glands.
Your doctor/pharmacist may
not prescribe it at all if you:
•
are allergic or sensitive to
or have had a reaction to
corticosteroids,
aminoglycosides
•
are allergic or sensitive to
neomycin or betamethasone
or
any
of
the
ingredients
listed
at
the
end
of
this
leaflet.
•
have
fungal,
viral
or
bacterial
infection
of
the
ear or eye
Betacin
contains
sodium
metabisulphite that may cause
serious allergic type reactions
in certain people. Do not use if
known to be hypersensitive to
bisulphites.
Do not use Betacin:
•
after the expiry date on the
pack;
•
if
the
packaging
shows
signs of tampering;
•
unless
advised
by
your
doctor
Ask your doctor or pharmacist
for
advice
before
taking
any
medicine.
-
_Before you start to use it _
Your
prescriber
may
only
prescribe
this
medicine
with
special care if you:
•
Have
disease
which
cause
thinning of the eye layers
•
Have
family
history
of
increased eye pressure
•
have had recent eye or n

Résumé des caractéristiques du produit

PHARMACODYNAMICS
PHARMACOKINETICS
0.5% w/v, Betamethasone Sodium Phosphate 0.1% w/v and
ROUTE OF ADMINISTRATION:
Eye and Ear
March 2021
15000
Co-treatment
with
CYP3A
inhibitors,
including
cobicistat-
containing products, is expected to increase the risk of systemic
side-effects.
The
combination
should
be
avoided
unless
the
benefit outweighs the increased risk of systemic corticosteroid
side-effects,
in
which
case
patients
should
be
monitored
for
systemic corticosteroid side-effects.
5ml x 12 bottles
_Product Registration Holder & Manufacturer:_
_ _
DUOPHARMA